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临床试验/NCT07470320
NCT07470320招募中不适用

Placental Biology in Health and Disease

University of Oxford1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2025年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
1
主要终点
Enhanced understanding of the molecular and cellular mechanisms linking placental EVs to maternal systemic inflammation in PET and GDM.

研究概览

简要总结

Pre-eclampsia (PET) is a condition characterised by high blood pressure and damage to other organs, and is a leading cause of maternal and fetal complications such as fetal growth restriction (FGR). Gestational diabetes mellitus (GDM) involves abnormal blood sugar levels during pregnancy and can have both short and long-term impacts on the health of the mother and child. Both conditions are linked to placental dysfunction but the precise mechanisms behind these links remain unclear.

A major focus of this study is on extracellular vesicles (EVs) which are tiny, bubble-like particles released by the placenta into the mother's and baby's bloodstreams. These EVs act as messengers, carrying proteins, lipids and genetic material that can influence how cells function, even in parts of the body far from the placenta. Notably, the number and content of these EVs change in conditions like PET and GDM, suggesting they may play a role in the development of these complications.

This single-site, observational, laboratory study aims to investigate how these EVs contribute to maternal health and disease. To enable analysis across different physiological and pathological conditions pregnant participants with healthy pregnancies, pregnancies predisposed to PET and pregnancies complicated by GDM, FGR and PET will be recruited alongside healthy non-pregnant controls. Recruitment will be from the Oxford University Hospitals NHS Foundation Trust and the Nuffield Department of Women's and Reproductive Health, University of Oxford (who fund the research). Demographic and clinical data will be collected as well as blood, urine, breath, voice, placenta, umbilical cord, umbilical cord blood, amniotic fluid and/or uterine vein blood samples.

Through examining EV content and function, it is hoped a better understanding of their role in pregnancy complications will be gained, including their potential as non-invasive biomarkers for early detection and targeted treatments, improving outcomes for mothers and babies worldwide.

详细描述

The study is a non-interventional, observational study focused on sample collection and laboratory-based analyses to investigate the role of placental EVs and soluble factors in maternal and fetal health. The study will focus on understanding the molecular mechanisms underlying pre-eclampsia, gestational diabetes mellitus and fetal growth restriction, with the ultimate aim of identifying biomarkers and therapeutic targets. To achieve this, the study will recruit participants with healthy, pathological and predisposed pregnancies alongside non-pregnant healthy controls.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female, aged 18 years or above
  • Willing and able to give informed consent for participation in the study
  • Able to read and understand written and spoken English to comprehend study materials and give informed consent
  • Non-pregnant women in good general health OR pregnant women who fall into one of the following:
  • Healthy pregnancy
  • Pre-eclampsia (PET) - defined by clinical diagnostic criteria, including hypertension and proteinuria
  • Gestational diabetes mellitus (GDM) - diagnosed by standard glucose tolerance tests during pregnancy
  • Fetal growth restriction (FGR) - diagnosed based on fetal weight or Doppler abnormalities
  • Predisposed to PET - high-risk factors for PET such as maternal type 1 or type 2 diabetes, autoimmune diseases or multiple pregnancies

排除标准

  • Non-pregnant participants with active health conditions that could confound study outcomes
  • Pregnant participants with conditions unrelated to PET, GDM or FGR that could influence EV profiles e.g. active infections or malignancies

研究组 & 干预措施

Pregnant women diagnosed with pre-eclampsia

干预措施: There are no interventions for this study (Other)

Pregnant women diagnosed with gestational diabetes mellitus

干预措施: There are no interventions for this study (Other)

Pregnant women diagnosed with fetal growth restriction

干预措施: There are no interventions for this study (Other)

Healthy pregnant women

干预措施: There are no interventions for this study (Other)

Healthy non-pregnant women

干预措施: There are no interventions for this study (Other)

Pregnant women predisposed to pre-eclampsia

干预措施: There are no interventions for this study (Other)

结局指标

主要结局

Enhanced understanding of the molecular and cellular mechanisms linking placental EVs to maternal systemic inflammation in PET and GDM.

时间窗: Baseline and at delivery

Quantitative (number of particles/ml) and qualitative differences (protein cargo) in EV profiles

次要结局

  • Quantitative and qualitative differences in inflammatory immune cells(baseline and delivery)
  • Sensitivity, specificity and predictive value of EVs for identifying PET, GDM and other pregnancy complications(Baseline and delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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